By Kate Rawson
Pfizer Inc.'s Lipitor was never going to go down without a fight.
The world’s best-selling prescription drug is about to lose patent protection, presenting generic drug companies with their biggest marketing opportunity ever. But potential fraud by first-filer Ranbaxy is complicating the generic landscape for Pfizer’s Lipitor. The stakes are high: How FDA resolves the Ranbaxy debacle will not only determine the winners of the Lipitor battle, but could drive big changes to the generic drug law.
By Kate Rawson
Pfizer Inc.'s Lipitor was never going to go down without a fight.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged liability under the False Claims Act linked to price-fixing allegations.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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